Table 1.
Overview of the study characteristics of the 6 publications that fulfilled the literature search and selection criteria.
| Year | Study Design | Nr Pts | Mean Age in Years | Gender (Male in %) | Aetiology HF (ICM in %) | NYHA Class (I/II/III/IV in %) | LVEF (in %) | FU Time in Months | Primary Endpoint | Secondary Endpoint | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehmer et al. (Multi SENSE study) | 2017 | Multicentre non-randomised trial | 974 | 67 | 71 | 52 | 4/64/25/1 | 30 | 12 | Predict sensitivity of 70% for heart failure event Alert 34 days prior to a HF event |
Unexplained alert rate of 1.47 per patient year |
| Gardner et al. | 2018 | MultiSENSE study post hoc analysis | 900 | 67 | 73 | 51 | 5/67/27/<1 | 30 | 12.9 | IN alert state associated with 0.80 events per patient year vs. OUT of alert with an event rate of 0.08 events per patient year Event ratio IN/OUT 10.6. |
50-fold risk of HF event when high NT-proBNP and IN alert vs. low NT-pro BNP and OUT alert state |
| Capucci et al. | 2019 | Retrospective case series | 67 | 71 | 81 | 37 | 4/50/44/2 | 30 | 5 ± 3 |
|
Unexplained alert rate of 0.41 per patient year |
| Calò et al. | 2020 | Multicentre prospective registry | 104 | 71 | 73 | 40 | 2/44/51/3 | 29 | - | S3 detects a restrictive filling pattern with 85% sensitivity and 82% specificity S1 detects LVEF < 35% with a 28% sensitivity and an 88% specificity |
More impairment of systolic and diastolic function was associated with more frequent signs of functional limitation and congestion |
| Santini et al. | 2020 | Multicentre prospective registry | 104 | 71 | 73 | 40 | 2/44/51/3 | 29 | 13 | 60% (60/100) of alerts were clinically meaningful 80% (48/60) of the clinical meaningful alerts were newly signalled by the algorithm 90% (43/48) of alerts triggered clinical action |
Alert-based management strategy more efficient than a scheduled monthly remote (phone call) follow-up scheme |
| Mitter et al. | 2020 | Retrospective case series | 38 | 60 | 76 | - | 18/63/18/0 | 32 | 3 | A significant drop in activity may have resulted in less congestion |
Nr pts, number of patients; HF, heart failure; ICM, ischemic cardiomyopathy; NYHA: New York Heart Association functional class; LVEF, left ventricular ejection fraction; FU, follow-up; NT- proBNP, N-terminal pro B-type natriuretic peptide; S1, 1st heart sound; S3, 3rd heart sound.